Back to FDA Applications sponsored by VALEANT PHARMS NORTH

FDA Drug Application 020648 by VALEANT PHARMS NORTH

Application Number020648
Application Type New Drug Application
Sponsor ApplicantVALEANT PHARMS NORTH
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/29/1997N13838000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm115425.htm 3/31/2006
AP08/25/1998SCS       
AP04/11/2001SLR17059002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020648_S002_DIASTAT_AP.pdf 7/6/2007
AP04/11/2001SLR5023002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20648S2ltr.pdf 4/11/2001
AP08/31/2000SCM       
AP010/17/2000SCM       
AP06/18/2002SCM       
AP09/15/2005SCS12816008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020648s008ltr.pdf 9/22/2005
AP09/15/2005SCS13834008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020648s008lbl.pdf 3/27/2006
AP09/15/2005SCS13835008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020648s008ppi.pdf 3/27/2006
AP08/29/2013SLR36935009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020648Orig1s009ltr.pdf 9/3/2013
AP012/16/2014SLR41286012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020648Orig1s012ltr.pdf 12/17/2014
AP012/16/2014SLR41289012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020648s012lbl.pdf 12/17/2014
AP010/27/2016SLR47537013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020648Orig1s013ltr.pdf 10/31/2016




Back to FDA Applications sponsored by VALEANT PHARMS NORTH